Regulatory Information
Management System
Management of product details, registrations, submissions and regulatory activities
Centralize your regulatory documentation, submissions, and compliance activities
Streamline regulatory processes, reducing manual tasks and redundant workflows
Proactively identify, assess, and mitigate regulatory risks
Easy Access to Key Regulatory Information Features
Centralized Management of Product Information
Maintain all data and specifications related to a pharmaceutical product, such as registration data, manufacturing details, labeling, packaging, and regulatory submissions, in a single, centralized location.
Automated Linking of Related Data
Streamline regulatory processes and improve data consistency and accuracy by automatically linking data on substances, products, registrations, activities, dossiers, submissions and documents.
Market Authorization and Registration Management
Streamline the regulatory submission process, reduce time-to-market for products, and ensure continued access to markets.
Regulatory Project Planning and Activity Tracking
Plan, coordinate, and monitor all regulatory activities related to product development, registration, and compliance.
Variation Change Control Management
Manage changes to regulatory variations such as product formulations, manufacturing processes, labeling, or other aspects that require approval from regulatory authorities.
Correspondence and Commitment Tracking
Manage interactions with regulatory agencies, fulfill regulatory obligations, and maintain compliance throughout the product lifecycle.
xEVMPD and SPOR Compliant
Dual terms and submission engine covering xEVMPD and SPOR to manage the transition, improving data accuracy and consistency.
Integrated Document Management and Publishing
Ensure efficient regulatory processes by an integration with document management (Ennov Doc) and submission (Ennov Dossier) modules.
Watch now: RIMS Implementation Roadmap
This video covers a 9-step roadmap to implement a Regulatory Information Management System, from initiation to project closure, sharing tips and tricks for vendor selection, system design, implementation, validation, and training.
End-to-end implementation support
As an implementation partner ION Pharma supports your project from start to finish. Starting with User Requirements Specifications to meet your specific needs all the way to system implementation and validation, and comprehensive training for trainers and end-users.
Implementation Types
- Out-of-the-Box – Standard Functionality to get you going
- ION Pharma’s Core Model – Industry Best Practice
- Turnkey – Client configured and ready to go
Rens van den Boomen
Rens has over 20 years of experience in pharma and biotech with knowledge of IT, RA, PV and QA. His sweet spot is working in complex environments where information, systems, people and processes meet.
Leveraging a Unified Platform
Designed for Regulated Content, Quality and Information Management
We believe the only way in achieving the availability of correct, complete, and compliant information, for the users that need to have it when they need to have it starts with a single unified system at the core of your processes. Therefore we partner with Ennov that has translated that philosophy in a single unified platform.
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Get ahead with a Regulatory Information Management System (RIMS)
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